Register Now
Why register?
 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - Pharmaceutical News - Alvogen Subsidiary Confirms ANDA Filing and Patent Challenge for Generic Revlimid - November 20, 2017

Pharmacy News Article

 9/11/17 - Alvogen Subsidiary Confirms ANDA Filing and Patent Challenge for Generic Revlimid

PINE BROOK, N.J.(BUSINESS WIRE) Alvogen subsidiary, Lotus Pharmaceuticals (Lotus), today announced that Celgene filed a suit on 6 September 2017 in the United States District Court for the District of New Jersey. The lawsuit was filed under provisions of the Hatch-Waxman Act, resulting in a stay of final Food and Drug Administration(FDA)approval of Lotus Abbreviated New Drug Application (ANDA) for up to 30 months from the date the plaintiffs, Celgene, received notice of Lotus' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

This Smart News Release features multimedia. View the full release here:

Robert Wessman Chairman and CEO (Photo: Business Wire)

Robert Wessman Chairman and CEO (Photo: Business Wire)

Lotus filed an ANDA with the United States FDA seeking regulatory approval to market a generic version of Revlimid. Lotus ANDA included a paragraph IV certification with respect to the patents listed in the FDA's listing of Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).

Lotus ANDA product is a generic version of Celgene's Revlimid 2.5, 5, 10, 15, 20 and 25 mg, which is indicated for the treatment of several hematological malignancies including multiple myeloma. The product was developed by Lotus pharmaceuticals in Taiwan.

Robert Wessman, Alvogen Chairman and CEO, said, The FDA acceptance of our ANDA filing is an important milestone for our U.S. business and great news for patients, who will finally have access to a more affordable treatment. I would like to thank our teams in the U.S. and Taiwan for their valuable efforts in submitting this filing.

Revlimid is a trademark of Celgene Corporation.

Alvogen currently has 75 products in development and pending FDA approvals for the U.S. market. Annual brand sales for filed products and those under development exceeds $25 billion, according to IMS Health (2015).

About Alvogen

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the US, Romania, Korea and Taiwan. North America is Alvogen's single largest market and other key markets include: South Korea, Russia, Hungary, Romania, Taiwan, Ukraine, Japan and China.

A consortium of investors, led by CVC Capital Partners and including Singapore-based investment company Temasek and Vatera Healthcare Partners, acquired a majority stake in Alvogen in June 2015.



Halldor Kristmannsson, (+354) 522-2900

Global Corporate Marketing & Media Relations

Source: Alvogen

Copyright Business Wire 2017

Pharmacy News Index
  Drug Delivery Systems
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry


Last Chance
Nov 20: Obesity Management: Overview of Pharmacotherapy
Last Chance
Nov 21: Standards of Practice for Filling Controlled Substance Prescriptions in Florida
Nov 22: Medical Marijuana: Examining the Science, Not the Politics
Nov 27: Drug Diversion and the Law: Updates and Considerations
Nov 28: An Integrative Approach to Managing Arthritis
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.

Websites »
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement